We are looking for a QA Operations Lead to oversee the day-to-day quality functions of our manufacturing site. In this pivotal leadership role, you will manage the workflow of the site QA team, ensuring that production schedules are met without compromising compliance. You will serve as the strategic bridge between the shop floor and senior Quality leadership, fostering a culture of "Quality First" across the site.
location: Morrisville, North Carolina
job type: Temporary
salary: $65 - 72 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Manage the daily allocation of QA resources to support manufacturing schedules, including shift coverage, batch record review timelines, and product release targets.
- Provide technical guidance and mentorship to QA Specialists. Foster their development in root cause analysis, technical writing, and risk assessment.
- Oversee the final disposition of raw materials, intermediates, and finished drug products. Ensure all deviations and change controls are closed prior to release.
- Represent Quality at site tier meetings. Work closely with Manufacturing, Supply Chain, and Engineering leadership to resolve escalated quality issues and mitigate risks to the production schedule.
- Maintain the site in a state of inspection readiness. Assist in hosting regulatory inspections and partner audits.
qualifications:
Required:
- B.S. in a scientific or engineering discipline.
- 7+ years of QA experience in a cGMP environment, with at least 2 years in a leadership or supervisory capacity.
- Deep expertise in Aseptic Processing and Biologics manufacturing.
- Gene Therapy/AAV experience
skills: Data Analysis, Assay Development, Assay Method, Assay Verification, Data Management Plan, Deviation Management, CRO Oversight, Cross Functional Collaboration, Data Security and Privacy, Corrective and Preventive Actions (CAPA), Change Control Management, Quality Assurance (QA), Aseptic Processing, Biologics Manufacturing, Batch Record, Data Interpretation and Presentation, Quality Management Systems (QMS)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
